RUSCH BRONCHOPART DOUBLE LUMEN LEFT
Received Jan 26, 2026 · Event occurred Jan 1, 2026
Report 8040412-2026-00007 · MDR key 24176147
Device
Generic name
Tube, Bronchial (w/wo Connect
Manufacturer
Teleflex MedicalCatalog number
116100-000370
Lot number
40E24K5387
Product problems
- Gas/Air Leak
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT."
Additional Manufacturer Narrative
(B)(4). THE REPORTED COMPLAINT OF CUFF LEAKAGE WAS CONFIRMED UPON INVESTIGATION OF THE RETURNED SAMPLE. THE CUSTOMER RETURNED ONE ACTUAL SAMPLE WITH ITS ORIGINAL PACKAGING. BASED ON THE FUNCTIONAL INSPECTION CONDUCTED ON THE RETURNED COMPLAINT, LEAKAGE WAS NOTED ON THE BRONCHIAL CUFF. FURTHER VISUAL INSPECTION UNDER THE DIGITAL MICROSCOPE, A LOCALIZED TEAR WAS OBSERVED ON THE CUFF SURFACE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. BASED ON THE INVESTIGATION, THE COMPLAINT OF LEAKAGE WAS CONFIRMED AND ATTRIBUTED TO A TEAR ON THE CUFF. HOWEVER, THE ROOT CAUSE OF THE DEFECT REMAINS UNDETERMINED AT THIS STAGE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
IT WAS REPORTED THAT: "(B)(6) 2026, THE DOCTOR FOUND CUFF LEAKAGE LEAKAGE WHEN DOING TESTING BEFORE USING ON PATIENT."